Galen Data

A Big Week on the Houston MedTech Calendar! Yesterday marked the conclusion of the Project Medtech Startup Symposium. A big thanks to Duane Mancini, M. Sc. and the Project Medtech team for featuring Alex as a panelist. The event delivered outstanding programming, with industry notables like Isabella S. of HeartSciences (NASDAQ:HSCS), Kyle Rose from Rook Quality Systems, and Kevin Saem, Ph.D. of Zapyrus—winner of MedTech World's Software Solution Provider of the Year. Some excellent companies pitched as well, including Tyler Melton from Corveus Medical, Bryon Wright from Kitea Health, and Werner Vorster of Vitls Inc, among the 25 selected. It was wonderful to see so many familiar faces in the room, including Jose Bohorquez from Bold Type, Weronika Michaluk, DrPH, MBA and Elise Mortensen from HTD Health, Dan Purvis from Velentium, and many more. For those we didn’t mention, it was a pleasure to reconnect, and we wish you all an excellent remainder of the year!

On December 10th, join us for our year-end webinar featuring Darcy Bachert from Prolucid Technologies! This session will focus on cybersecurity strategies for medical device software. As medical devices become increasingly cloud-connected, ensuring their security has never been more critical. We'll dive into four key areas: - Threat Modeling - Risk Assessment - SBOM Management - Post-Market Monitoring for Cybersecurity Whether you're a medical device developer, quality assurance professional, regulatory affairs specialist, or cybersecurity expert, this webinar will equip you with practical tools and insights to strengthen your cybersecurity posture and mitigate risks associated with connected medical devices. Key Takeaways: - Threat Modeling for Medical Devices: Learn to identify and address security threats during the design and development phases, ensuring patient safety. - Risk Assessment in Healthcare Devices: Understand how to evaluate cybersecurity risks in medical devices, including compliance with FDA guidelines, IEC 62304, and other industry standards. - SBOM Management for Medical Devices: Explore strategies for managing Software Bills of Materials (SBOMs) to enhance supply chain visibility and mitigate vulnerabilities in third-party software components. - Post-Market Cybersecurity Monitoring: Discover how to implement continuous monitoring plans for medical devices in use, enabling prompt responses to emerging threats while maintaining regulatory compliance. Here is a link to register: https://lnkd.in/gWx84Jys

With a global pandemic and the meteoric rise of artificial intelligence (AI), history may view the first half of this decade as one of the most disruptive in the history of medtech. As we approach 2025, emerging technologies continue to impact device design and capabilities. For founders and consultants in the medical device market, staying informed about tech and regulatory trends for the advanced medical device industry in 2025 is essential for maintaining a competitive edge. This blog explores the critical technological and regulatory trends shaping 2025, helping medical device leaders prepare for an innovative, compliant, and patient-centered future. https://buff.ly/4fVE4Rd

Next week on Tuesday and Wednesday, November 19th and 20th, Duane Mancini, M. Sc., and Project Medtech will be at the Texas Medical Center Innovation Factory for their 3rd Annual Startup Symposium! We’re honored to be speaking again this year and look forward to seeing friends from around the country converge in Houston for great learning and networking opportunities. The speaker list is below, and startup companies are sure to walk away with a lot of actionable insights! We hope to see you there! To Register, please click here: https://lnkd.in/ewmnN3Ri

First and foremost, a huge congratulations to Dylan Attard MD, MRCSI, MEnt. and MedTech World & Giovanni Lauricella and the team at Lifeblood for organizing another fantastic #MedTechMalta this year! This conference is more than just a gathering of professionals; it’s truly a gathering of friends. Seeing the group grow and witnessing like-minded people come together in such a unique location is inspiring...we can’t wait to see what great things lie ahead! We’d like to extend our thanks to the organizers once again for letting our own COO Alex Condon share a stage with Tyler Melton, Savannah Esteve Morreale, Rafael J. Veraza, PhD, MPH, Werner Vorster, and Tushar Sharma. It was an honor to sit beside such an outstanding group of founders and leaders. Another shoutout goes to the intrepid group who joined us at 7:00 a.m. to explore the beautiful city of Mdina in the wind and rain. Always a pleasure to be in your company come rain or shine, Youssef Helwa, Steven Levy, Homer Quintana, and Tushar Sharma. A big congratulations to Kevin Saem, Ph.D. and the wonderful team at Zapyrus for winning the Best Software Solution Provider of the Year Award! It’s a well-deserved recognition, and we couldn’t be happier for you. We were fortunate winners last year, and we’re thrilled to see the trophy in the hands of such a deserving team. Lastly, but by no means least, we’d like to thank the 20 or so friends who joined us for dinner at the Xara Palace Hotel the night before the conference. It was a magical evening in a magical setting, and we feel fortunate and humbled to call you all our friends on this shared medtech journey. There are countless others from across the globe with whom it was wonderful to reconnect—and new friends to meet and shake hands with for the first time. We made great connections during our brief visit and plenty of unforgettable memories to carry into next year.

Don’t miss your chance to join this morning’s webinar at 11:30 AM ET, where Jung en (Andrew) Wu of Rook Quality Systems and Galen Data's own CTO, Abbas Dhilawala will explore how to seamlessly integrate MLOps with established software lifecycle standards. This session will cover key strategies for overcoming data integration, privacy, and deployment challenges, along with practical solutions for efficient data pipelines and synchronized DevOps/MLOps processes. Also discussed will be best practices for model monitoring, scaling, and aligning with FDA regulations like PCCP. This session will be great for those wanting to boost their MLOps efficiency while ensuring compliance. Hope to see you all there! To Register: https://lnkd.in/gNWJcGBW

Join Galen Data and Rook Quality Systems on November 11th at 10:30 AM CT for an in-depth discussion on how to optimize #MLOps while ensuring regulatory compliance, data privacy, and efficient deployment in the #cloud. We will discuss ● Solutions for overcoming common challenges in data integration, security, and privacy ●?Best practices for building efficient data pipelines and synchronizing DevOps with MLOps ●?How to align MLOps with FDA regulatory requirements, including the Predetermined Change Control Plan (PCCP) ●?Practical insights on model monitoring, scaling, and performance optimization ●?How Galen Data and Rook Quality Systems can support your MLOps needs Cant join? Register anyways and we will send you the recoding of the webinar. Register here : https://lnkd.in/gqtHvRbb

Recently, Frank Jaskulke from Avio Medtech Consulting joined a Galen Data webinar to talk about 10 common mistakes medical device companies make when going to market. The first one was market validation. Many companies try to solve a problem they see or have faced, but it's important to know if the problem is big enough to build a business around. As Frank says, "Not all clinical problems are business problems." Listen to this short clip for more details about market validation. You can find the link to the entire webinar in the comments.

People often view successful innovation as kind of like achieving “overnight success”. In reality, successful teams bringing innovation to the marketplace know that the process is a long, challenging marathon of problem-solving and collaboration. Of all the fields that work with emerging technologies, advanced medical device product development has one of the most complex journeys. Medical device development requires technical innovation and a deep understanding of regulatory requirements, patient safety, and market needs. In this blog discover the 5 essential steps to bring your advanced medical device to market, streamline your development process and ensure compliance. https://buff.ly/40cw61i

Great article from MedTech Dive highlighting a growing cybersecurity risk: the vulnerability of legacy medical devices with outdated software to cyber threats. Galen Data, along with our partner mdeg - Medical Device Engineering Group, can address this pressing issue by enabling secure cloud connectivity, allowing device manufacturers to deploy updates and monitor device health remotely. Our platform also enables insights into device usage and predictive maintenance, reducing downtime and enhancing safety. With our configurable solution, medical device companies can quickly boost security for legacy devices while extending their lifecycle. Connect with us to see how we can help transform your legacy products to meet today’s cybersecurity demands. For more info, please reach out to [email protected] https://lnkd.in/gj6NC7AG